Konica Minolta Medical & Graphic, Inc.
Hachioji-Shi Tokyo, JP
Konica Minolta Medical & Graphic, Inc. appears in FDA device records in Hachioji-Shi Tokyo, JP. FDA records list 27 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 27
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 27 510(k) clearances for Konica Minolta Medical & Graphic, Inc. between 2002 and 2013. The busiest year on record is 2005, with 6. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 3 |
| 2004 | 2 |
| 2005 | 6 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 3 |
| 2012 | 6 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K130936 | AERODR SYSTEM WITH P-31 | MQB | Substantially Equivalent | |
| K123499 | AEROPILOT | MQB | Substantially Equivalent | |
| K120752 | AERODR STITCHING SYSTEM | KPR | Substantially Equivalent | |
| K121109 | AERODR X70 | KPR | Substantially Equivalent | |
| K120477 | AEROSYNC FOR AERODR SYSTEM | MQB | Substantially Equivalent | |
| K120131 | REGIUS SIGMA2 | MQB | Substantially Equivalent | |
| K113248 | AERODR SYSTEM WITH P-21 | KPR | Substantially Equivalent | |
| K110717 | KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM | MUE | Substantially Equivalent | |
| K103703 | REGUIS SIGMA | MQB | Substantially Equivalent | |
| K101842 | ACIES | LLZ | Substantially Equivalent | |
| K102349 | AERODR SYSTEM | KPR | Substantially Equivalent | |
| K092717 | DIRECT DIGITIZER, REGIUS MODEL 210 | MQB | Substantially Equivalent | |
| K081637 | LASER IMAGER DRYPRO MODEL 873 | LMC | Substantially Equivalent | |
| K071436 | REGIUS UNITEA | LLZ | Substantially Equivalent | |
| K071181 | DIRECT DIGITIZER, REGIUS MODEL 110 | MQB | Substantially Equivalent | |
| K061999 | DRY LASER IMAGER, DRYPRO MODEL 832 | LMC | Substantially Equivalent | |
| K053173 | DS CASSETTE | IXA | Substantially Equivalent | |
| K052095 | MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190 | MQB | Substantially Equivalent | |
| K051998 | REGIUS MODEL 170 DIRECT DIGITIZER | MQB | Substantially Equivalent | |
| K051523 | REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION | LLZ | Substantially Equivalent | |
| K051418 | DIRECT DIGITIZER REGIUS MODEL 370 | MQB | Substantially Equivalent | |
| K051521 | REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION | LLZ | Substantially Equivalent | |
| K042386 | DIRECT DIGITIZER, REGIUS MODEL 190 | MQB | Substantially Equivalent | |
| K042133 | DRY LASER IMAGER, MODEL DRYPRO MODEL 793 | LMC | Substantially Equivalent | |
| K023061 | KONICA DIRECT DIGITIZER REGIUS, MODEL 170 | MQB | Substantially Equivalent | |
| K013054 | KONICA DIRECT DIGITIZER REGIUS MODEL 350 | MQB | Substantially Equivalent | |
| K013052 | KONICA LASER IMAGER, DRYPRO MODEL 751/752 | LMC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Konica Minolta Medical & Graphic, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Konica Minolta Medical & Graphic, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain